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Examining Expectancy Challenges to Prevent Nonmedical Prescription Stimulant Use

NCT ID: NCT03648684

Last Updated: 2020-11-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

131 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-04

Study Completion Date

2020-10-01

Brief Summary

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Nonmedical prescription stimulant use (NPS) is commonly reported among college students for cognitive enhancement purposes, though it is associated with numerous negative psychological and physical consequences. Despite increasingly high prevalence rates and widespread acknowledgement of the need for efficacious interventions, little is known regarding how to prevent or treat this behavior. An intervention that targets cognitive enhancement motives and expectancy effects related to NPS may be particularly effective in light of recent research purporting limited evidence for meaningful NPS-related cognitive improvements among individuals without legitimate attention deficits. The primary objective of this proposal is to examine the efficacy of an intervention that successfully prevents NPS among college students by modifying expectations for NPS-related effects, while at the same time providing alternative means of enhancing cognition and arousal. Participants will be 126 stimulant-naïve college students who report a combination of risk factors for NPS. They will be randomized to one of three treatment conditions: a placebo-based expectancy challenge intervention that solely aims to modify expectancies related to NPS, a caffeine-based expectancy challenge intervention that includes expectancy modification combined with a safer alternative for cognitive enhancement, or a control group. Multilevel mixed modeling and survival analyses will be used to 1) examine changes in NPS-related expectancy effects across a 6-month follow-up period, and 2) assess incidence of NPS over the follow-up period, respectively, across the three groups. It is hypothesized that both expectancy challenge interventions will successfully modify expectancies compared to the control group and that they will be maintained over the follow-up period. It is also expected that the caffeine-based intervention will most successfully prevent NPS through a combination of expectancy modification and encouraging safe use of caffeine rather than prescription stimulants to achieve desired outcomes. Mediational analyses will also be employed to assess whether changes in expectancy effects via the interventions are responsible for differences in initiation rates between groups. The results of this project will facilitate the development of larger-scale prevention efforts to target the high rate of NPS on college campuses.

Detailed Description

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Conditions

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Prescription Drug Abuse (Not Dependent)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Caffeine-Based Expectancy Challenge

Participants will ingest caffeine under the guise of Adderall prior to completing tasks. They will engage in an expectancy challenge intervention designed to both challenge expectancies for prescription stimulants and promote safe caffeine use for cognitive/mood enhancement.

Group Type EXPERIMENTAL

Caffeine-Based Expectancy Challenge

Intervention Type BEHAVIORAL

Intervention to alter expectancies and encourage safe drug substitution (harm reduction plus expectancy modification)

Placebo-Based Expectancy Challenge

Participants will ingest placebo under the guise of Adderall prior to completing tasks. They will engage in an expectancy challenge intervention designed to challenge expectancies for prescription stimulants.

Group Type PLACEBO_COMPARATOR

Placebo-Based Expectancy Challenge

Intervention Type BEHAVIORAL

Intervention to alter expectancies (expectancy modification only)

Control

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Caffeine-Based Expectancy Challenge

Intervention to alter expectancies and encourage safe drug substitution (harm reduction plus expectancy modification)

Intervention Type BEHAVIORAL

Placebo-Based Expectancy Challenge

Intervention to alter expectancies (expectancy modification only)

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Native English speakers
* Current undergraduate enrollment
* Prescription stimulant naive
* At-risk for nonmedical prescription stimulant use, defined by endorsement of 2+ risk factors: male sex OR white race, Greek involvement, GPA \< 3.5, past two-week binge drinking, past-month marijuana
* Willingness to ingest Adderall in the laboratory
* Past-month caffeine use

Exclusion Criteria

* Lifetime history of use of any prescription stimulant
* Current psychiatric diagnosis
* Current psychiatric medication use
* Smoking \> 5 cigarettes daily or daily use of any other nicotine product
* History of cardiac problems, diabetes, or regular hypoglycemia
* Current pregnancy or breastfeeding
* History of adverse reactions to caffeine
Minimum Eligible Age

18 Years

Maximum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Wyoming

OTHER

Sponsor Role lead

Responsible Party

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Alison Looby

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Alison Looby, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Wyoming

Locations

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University of Wyoming

Laramie, Wyoming, United States

Site Status

Countries

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United States

References

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Looby A, Piccorelli AV, Zimmerman L, Falco C, Livingston NR, Akin C, Benton S, Juliano LM. Expectancy for Adderall influences subjective mood and drug effects regardless of concurrent caffeine ingestion: A randomized controlled trial. Psychopharmacology (Berl). 2024 Jan;241(1):109-118. doi: 10.1007/s00213-023-06467-8. Epub 2023 Sep 23.

Reference Type DERIVED
PMID: 37740001 (View on PubMed)

Other Identifiers

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20180620AL02017

Identifier Type: -

Identifier Source: org_study_id